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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00430300
Registration number
NCT00430300
Ethics application status
Date submitted
30/01/2007
Date registered
1/02/2007
Date last updated
8/07/2013
Titles & IDs
Public title
Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.
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Scientific title
A Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group Study To Evaluate the Efficacy And Safety of UK-432,097 Dry Powder For Inhalation In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease.
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Secondary ID [1]
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A3971013
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - UK-432,097
Treatment: Drugs - Placebo
Experimental: 150mcg, 450mcg or 1350mcg - Active treatment given BID via a double pin monodose capsule inhaler device
Placebo comparator: Placebo - Placebo treatment given BID via a single pin monodose inhaler device
Treatment: Drugs: UK-432,097
Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.
Treatment: Drugs: Placebo
Capsules containing 100% lactose administered BID using an atomizer device
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
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Assessment method [1]
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FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
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Timepoint [1]
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Pre-dose at Baseline, Week 6
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Secondary outcome [1]
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
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Assessment method [1]
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FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
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Timepoint [1]
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Pre-dose at Baseline, Week 2, 4, 8
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Secondary outcome [2]
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Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8
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Assessment method [2]
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FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration.
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Timepoint [2]
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Pre-dose at Baseline, Week 2, 4, 6, 8
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Secondary outcome [3]
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Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8
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Assessment method [3]
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FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
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Timepoint [3]
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Pre-dose at Baseline, Week 2, 4, 6, 8
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Secondary outcome [4]
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Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8
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Assessment method [4]
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IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration.
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Timepoint [4]
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Pre-dose at Baseline, Week 2, 4, 6, 8
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Secondary outcome [5]
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Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6
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Assessment method [5]
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FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration.
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Timepoint [5]
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15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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Secondary outcome [6]
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Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6
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Assessment method [6]
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FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration.
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Timepoint [6]
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15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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Secondary outcome [7]
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Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6
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Assessment method [7]
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FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration.
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Timepoint [7]
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15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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Secondary outcome [8]
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Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6
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Assessment method [8]
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IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration.
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Timepoint [8]
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15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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Secondary outcome [9]
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Change From Baseline in Post-Bronchodilator FEV1 at Week 6
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Assessment method [9]
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FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
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Timepoint [9]
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15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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Secondary outcome [10]
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Change From Baseline in Post-Bronchodilator FEV6 at Week 6
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Assessment method [10]
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FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
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Timepoint [10]
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15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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Secondary outcome [11]
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Change From Baseline in Post-Bronchodilator FVC at Week 6
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Assessment method [11]
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FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
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Timepoint [11]
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15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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Secondary outcome [12]
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Change From Baseline in Post-Bronchodilator IC at Week 6
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Assessment method [12]
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IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
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Timepoint [12]
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15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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Secondary outcome [13]
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Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6
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Assessment method [13]
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BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains.
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Timepoint [13]
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Baseline, Week 2, 4, 6
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Secondary outcome [14]
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Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8
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Assessment method [14]
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COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant's daily score for each symptom was averaged over each week.
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Timepoint [14]
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Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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Secondary outcome [15]
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Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8
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Assessment method [15]
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Participants were issued with rescue medication (Salbutamol MDI \[100 mcg/actuation\]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant's daily use (puffs/day) was averaged over each week.
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Timepoint [15]
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Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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Secondary outcome [16]
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Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8
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Assessment method [16]
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The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant's daily values were averaged over each week.
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Timepoint [16]
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Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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Secondary outcome [17]
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Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)
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Assessment method [17]
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CGI-C: clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
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Timepoint [17]
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Week 6
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Secondary outcome [18]
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Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
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Assessment method [18]
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PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
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Timepoint [18]
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Week 6
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Eligibility
Key inclusion criteria
* Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease
* Patients must have a smoking history of at least 10 pack-years
* Patients must have stable disease for at least 1 month prior to screening.
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Minimum age
40
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* More than 2 exacerbations of COPD in the preceding year
* History of a lower respiratory tract infection or significant disease instability during the month proceding screening or during the time between screen and randomization.
* History or presence of respiratory failure, cor pulmonale or right ventricular failure
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2008
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Sample size
Target
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Accrual to date
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Final
87
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
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Recruitment hospital [1]
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Pfizer Investigational Site - Camperdown
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Recruitment hospital [2]
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Pfizer Investigational Site - Glebe
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Recruitment hospital [3]
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Pfizer Investigational Site - Daw Park
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Recruitment hospital [4]
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Pfizer Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2037 - Glebe
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Recruitment postcode(s) [3]
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5041 - Daw Park
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Canada
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State/province [2]
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Ontario
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Canada
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State/province [3]
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Quebec
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Country [4]
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Netherlands
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State/province [4]
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Almelo
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Country [5]
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Netherlands
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State/province [5]
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Eindhoven
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Country [6]
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Netherlands
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State/province [6]
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Zuthpen
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Country [7]
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Poland
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State/province [7]
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Bydgoszcz
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Poland
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State/province [8]
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Gdansk
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Poland
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State/province [9]
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Lodz
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Poland
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State/province [10]
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Warszawa
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Country [11]
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United Kingdom
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State/province [11]
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Surrey
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Country [12]
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United Kingdom
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State/province [12]
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Leicester
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Country [13]
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United Kingdom
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State/province [13]
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London
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Country [14]
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United Kingdom
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State/province [14]
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Manchester
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Country [15]
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United Kingdom
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State/province [15]
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Newcastle upon Tyne
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Country [16]
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United Kingdom
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State/province [16]
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.
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Trial website
https://clinicaltrials.gov/study/NCT00430300
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00430300
Download to PDF